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Pharmaceutical Compliance Specialist
Lifelancer. Support the REMS Call Center program to help ensure FDA-mandated requirements and goals are met .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Risk Evaluation and Mitigation Strategy (REMS) compliance, call center operations, and effective communication within the pharmaceutical and healthcare industry. Proficient in conducting investigations, managing compliance duties, and providing training to stakeholders.
Highest-signal resume keywords
Risk Evaluation And Mitigation Strategy (REMS)Call Center OperationsHealthcare ComplianceAnalytical And Problem-Solving SkillsMicrosoft Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Compliance InvestigationData Entry SkillsProgram Compliance DutiesStakeholder CoordinationAuditing And Monitoring Activities
Soft Skills
Clear Communication SkillsTeam CollaborationPositive AttitudeMultitasking AbilityOrganizational Skills
Tools & Technologies
Investigation DatabasesCase Management SystemsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Industry Keywords
FDA RequirementsConfidentialityHealthcare Provider Follow-UpNon-Compliance DocumentationCustomer Service Etiquette
About the role
Key responsibilities & impact- Support the REMS Call Center program to help ensure FDA-mandated requirements and goals are met
- Conduct investigations of potential non-compliance within REMS programs
- Manage prompt, thorough, confidential, and objective investigations in accordance with Syneos Health and REMS Program requirements
- Complete program compliance duties, including stakeholder re-education, documentation of non-compliant events, review of alerts/reminders, and healthcare provider/pharmacy follow-up
- Coordinate corrective actions with stakeholders and ensure timely implementation
- Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements
- Engage in REMS program auditing and/or monitoring activities
Requirements
What you’ll need- Bachelor’s Degree required
- Experience with Risk Evaluation and Mitigation Strategy (REMS)
- Knowledge of call center operations and processes
- One or more years of experience in the pharmaceutical or healthcare industry, with emphasis on compliance
- Telephone and/or customer service experience and etiquette
- Efficient computer and data entry skills; ability to learn new systems and programs quickly
- Ability to work with a team and maintain a positive attitude
- Clear and effective written and verbal communication skills
- Ability to multitask, prioritize day-to-day responsibilities, and meet deadlines
- Excellent analytical, problem-solving, and organizational skills
- Experience in a high-pressure and fast-paced environment
- Ability to maintain confidentiality involving compliance and company information and activities
- Current working knowledge of rules, regulations, and industry guidance relevant to healthcare compliance
- Ability to communicate effectively with Engagement Center representatives, internal departments, clients, and management
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail program
- Proficiency with investigation databases and case management systems and tools
Benefits
Comp & perks- Competitive compensation package
- Medical, dental, and vision health benefits
- Company match 401(k)
- Flexible paid time off (PTO)
- Sick time
- Diverse, inclusive, and authentic workplace
- Support, resources, and autonomy
- Opportunities to develop and advance
- Voluntary COVID-19 vaccination policy; vaccination may be required by certain local governments or customers